Perioperative Administration of Pregabalin for Pain After Septoplasty

NCT ID: NCT01370915

Last Updated: 2011-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-12-31

Brief Summary

Pregabalin is used for the treatment of neuropathic pain and has shown analgesic efficacy in postoperative pain. The aim of this randomized, double-blinded, placebo-controlled trial was to investigate the efficacy and safety of pregabalin for reducing postoperative pain in patients after septoplasty. Persons who scheduled for elective septoplasty under general anesthesia were randomly assigned to groups that received either pregabalin (150 mg twice) or placebo, one hour before surgery and 12 hours after the initial dose. Assessments of pain (verbal numerical rating scale) and side effects were performed at one, six, 12, and 24 hours postoperatively.

Detailed Description

Pregabalin is used for the treatment of neuropathic pain and has shown analgesic efficacy in postoperative pain. The aim of this randomized, double-blinded, placebo-controlled trial was to investigate the efficacy and safety of pregabalin for reducing postoperative pain in patients after septoplasty. Patients will be randomly assigned to one of two groups to receive either pregabalin (Lyrica®, Pfizer, Inc.) or placebo (vitamin complex). According to their assigned study group, patients received either pregabalin (75 mg) or placebo twice, one hour before surgery and 12 hours after the initial dose. The assessment of pain and side effects, such as nausea and vomiting, headache, dizziness, sedation, and blurred vision, were made at one, six, 12, and 24 hours postoperatively.

Conditions

Deviated Nasal Septum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Pregabalin

Patients receive oral placebo 150 mg 1hour prior to septal surgery, and 12 hours later

Group Type: EXPERIMENTAL

Pregabalin (Lyrica)

Intervention Type: DRUG

Patients receive oral Pregabalin 150 mg 1 hour before septal surgery, and 12 hours later

Placebo

Patients receive oral Placebo(Vitamin complex) 150 mg 1 hour before septal surgery, and 12 hours later

Group Type: PLACEBO_COMPARATOR

Vitamin complex (placebo)

Intervention Type: DRUG

Patients receive oral Placebo(Vitamin complex) 150 mg 1 hour before septal surgery, and 12 hours later

Interventions

Pregabalin (Lyrica)

Patients receive oral Pregabalin 150 mg 1 hour before septal surgery, and 12 hours later

Intervention Type: DRUG

Vitamin complex (placebo)

Patients receive oral Placebo(Vitamin complex) 150 mg 1 hour before septal surgery, and 12 hours later

Intervention Type: DRUG

Other Intervention Names

pregabalin; placebo, vitamin complex

Eligibility Criteria

Inclusion Criteria

• Age 20 ≥ and ≤ 65 years
• Patients with nasal packing after septoplasty

Exclusion Criteria

• previous septal surgery history
• postoperative complications including septal hematoma, bleeding ets.
• Current therapy with pregabalin, gabapentin, or any opioid
• Renal insufficiency
• History of seizure disorder

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Samsung Medical Center

Principal Investigators

Hun Jong Dhong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center, Department of Otorhinolaryngoloty

Locations

Department of Otorhinolaryngology H&N surgery, Sungkyunkwan University College of Medicine, Samsung Seoul Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

JOON HO KIM

Role: primary

juno0077.kim@samsung.com

82-2-3410-3579

Other Identifiers

2010-06-012

Identifier Type: -

Identifier Source: org_study_id